Final analysis of GIDEON (Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma [HCC] and of Its Treatment with Sorafenib [Sor]) in >3000 Sor-treated patients (pts): Clinical findings in pts with liver dysfunction.

Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
General Poster Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr 4126)
Jorge A. Marrero, Riccardo Lencioni, Sheng-Long Ye, Masatoshi Kudo, Jean-Pierre Bronowicki, Xiao-Ping Chen, Lucy Dagher, Junji Furuse, Jean-Francois Geschwind, Laura Ladrón de Guevara, Christos Papandreou, Arun J. Sanyal, Tadatoshi Takayama, Seung Kew Yoon, Keiko Nakajima, Alan Paul Venook; The University of Texas Southwestern Medical Center, Dallas, TX; Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy; Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China; Kinki University School of Medicine, Department of Gastroenterology and Hepatology, Osaka, Japan; Department of Gastroenterology and Hepatology, Inserm U954, University Hospital of Nancy, University Henri Poincaré, Vandœuvre-lès-Nancy, France; Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Department of Surgery, Wuhan, China; Políclinica Metropolitana, Caracas, Venezuela; Department of Internal Medicine, Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan; The Johns Hopkins University School of Medicine, Baltimore, MD; Hospital Angeles Clínica Londres, Mexico City, Mexico; Faculty of Medicine, University of Larissa, Larissa, Greece; Virginia Commonwealth University Medical Center, Richmond, VA; Nihon University School of Medicine, Department of Digestive Surgery, Tokyo, Japan; The Catholic University of Korea, Seoul, South Korea; Bayer HealthCare Pharmaceuticals, Montville, NJ; University of California, San Francisco, San Francisco, CA

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures


Background: GIDEON is a prospective, non-interventional study. Completion of GIDEON creates a large, global database of >3000 Sor-treated unresectable HCC (uHCC) pts, allowing for evaluation of a broad pt population, including Child-Pugh (CP) B pts with more advanced liver dysfunction. Methods: Baseline characteristics were collected in pts for whom a decision to treat with Sor had been made in clinical practice. Adverse events (AEs), dosing, and outcomes data were collected during follow-up. Results: 3,202 pts were evaluable for safety. Overall, the incidence of AEs and drug-related (DR) AEs was similar across CP subgroups, although serious AEs (SAEs) were more common in CP-B than CP-A pts. The rate of DR AEs (event per patient-year) was also comparable between CP-A and CP-B pts. The average daily Sor dose was slightly higher in CP-B than CP-A pts; duration of treatment was longer in CP-A (Table). In the intent-to-treat population (n=3,213), median overall survival (OS) (months [95% CI]) was longer in CP-A (13.6 [12.8-14.7]) than CP-B pts (5.2 [4.6-6.3]); time to progression was similar: CP-A (4.7 [4.3-5.2]); CP-B (4.4 [3.5-5.5]). Median OS was shorter in pts with a higher CP-B score: 7 (6.2 [4.9-8.7]); 8 (4.8 [4.1-6.9]); 9 (3.7 [3.0-5.1]). Conclusions: Sor safety and dosing during treatment are generally consistent across pts irrespective of liver function. As anticipated, CP status is a strong prognostic factor for OS in uHCC pts.

N=3202a (100)
n=1968 (61.5)
n=666 (20.8)
All DR All DR All DR
AEs, %b
All grades 85.3 66.0 84.0 68.5 88.6 64.4
Grade 3/4 31.7 23.5 32.4 25.6 31.5 21.9
SAEs 43.3 9.3 36.0 8.8 60.4 14.1
AE rate (event per patient-year)b,c
Any AE 1.61 1.24 1.44 1.17 2.14 1.55
Diarrhea 0.58 0.51 0.54 0.48 0.71 0.62
Hand-foot skin reaction 0.51 0.50 0.55 0.54 0.42 0.41
Fatigue 0.45 0.29 0.38 0.27 0.62 0.34
Discontinuation due to AEs, %b 31.4 28.9 40.1
Daily dose, median, mgd 688.0 677.0 741.5
Treatment duration, median, weeksd 15.0 17.6 9.9

aIncludes CP-C, 74 pts; not evaluable, 493 pts; bTreatment-emergent; cCalculated based on 365.25 days per year; dPts with dosing data.